2014年9月26日訊 /生物谷BIOON/ --導讀：勃林格殷格翰是呼吸疾病領域的領導者，該公司開發的COPD新藥Spiriva Respimat於2007年被FDA拒絕。之後開展了全球最大的COPD臨床研究，證明了療效和安全性。近日，FDA終於批准Spiriva Respimat，該藥與COPD市場中處方量排名第一的藥物Spiriva HandiHaler具有相同的成分，但前者的氣霧配方具有舒適性及便利性優勢，尤其將使初診COPD患者群體受益。業界預測，Spiriva Respimat將取代Spiriva HandiHaler，成為COPD市場的領導者，並實現重磅銷售。
勃林格殷格翰（Boehringer Ingelheim）近日宣布，FDA已批准Spiriva Respimat（tiotropium bromide，噻託嗅按）吸入氣霧劑，作為一種長期的、每日一次的維持性藥物，用於慢性阻塞性肺病（COPD，包括慢性支氣管炎和肺氣腫）支氣管痙攣的治療，以及減少COPD急性加重。Spiriva Respimat將為COPD提供一種重要的治療選擇，尤其是初診COPD患者。
Spiriva Respimat具有與已上市藥物Spiriva HandiHaler相同的活性成分（噻託溴銨粉吸入劑），在美國，Spiriva HandiHaler是處方量排名第一的COPD維持藥物，勃林格表示，該藥將繼續作為COPD患者的一種治療選擇。Spiriva Respimat的開發，旨在不依賴空氣快速通過吸入器的方式遞送藥物，而是通過一種緩慢移動的氣霧遞送定量的藥物。勃林格計劃於2015年1月將Spiriva Respimat推向市場。
FDA曾於2007年拒絕批准Spiriva Respimat，理由是安全性問題及缺乏療效證據。此次，勃林格開展了迄今為止在COPD患者中開展的最大臨床研究TIOSPIR，該項研究涉及17135例COPD患者，數據表明，Spiriva Respimat療效媲美Spiriva HandiHaler。該項研究的領導者表示，Spiriva Respimat的氣霧配方，尤其將使初診COPD患者群體受益，與Spiriva HandiHaler乾粉配方相比，氣霧配方舒適性及便利性更好。
今年8月，FDA肺過敏藥物諮詢委員會（PADAC）也建議批准Spiriva Respimat。該委員會認為，Spiriva Respimat能夠有效減少支氣管痙攣和COPD急性加重，同時全因死亡方面無顯著風險。
今年7月，FDA也批准了勃林格另一款基於Respimat氣霧吸入器的COPD藥物Striverdi Respimat。（生物谷Bioon.com）
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英文原文：Boehringer Ingelheim Announces FDA Approval of Spiriva? Respimat? (tiotropium bromide) Inhalation Spray for the Maintenance Treatment of COPD
RIDGEFIELD, Conn., Sept. 25, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Spiriva? Respimat? (tiotropium bromide) inhalation spray for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. Boehringer Ingelheim anticipates SPIRIVA RESPIMAT to be available in January 2015.
SPIRIVA RESPIMAT provides a pre-measured amount of medicine in a slow-moving mist that helps patients inhale the medicine. SPIRIVA RESPIMAT was developed to actively deliver medication in a way that does not depend on how fast air is breathed in from the inhaler.
SPIRIVA RESPIMAT has the same active ingredient as Spiriva? HandiHaler? (tiotropium bromide inhalation powder), which is the number one branded prescription medication for COPD maintenance in the United States. SPIRIVA HandiHaler will continue to be available as a treatment option.
"SPIRIVA RESPIMAT offers a new choice between a mist and dry powder inhaler for tiotropium," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Already approved in 85 countries around the world, SPIRIVA RESPIMAT reflects our scientific heritage as an industry leader in discovering and developing new treatment options for the COPD community."
The approval of SPIRIVA RESPIMAT is based on data from seven clinical trials in which 8,700 patients were treated with SPIRIVA RESPIMAT. One of these trials, TIOSPIR?, the largest clinical trial conducted to date in patients with COPD, collected data from more than 5,700 patients treated with SPIRIVA RESPIMAT and nearly 5,700 patients treated with SPIRIVA HandiHaler.
The most common side effects reported with SPIRIVA RESPIMAT include sore throat, cough, dry mouth and sinus infection.
"COPD is a chronic condition that requires highly individualized treatment for optimal disease management. It's essential to have multiple choices available for healthcare providers and patients," said Stephen Rennard, M.D., Professor, Internal Medicine, Division of Pulmonary, Critical Care, Sleep & Allergy, University of Nebraska Medical Center. "Each inhaler option has different features that a healthcare provider and patient might decide are more suitable for their specific situation."
The RESPIMAT is the platform inhaler for the Boehringer Ingelheim suite of inhaled bronchodilators, including approved and investigational therapies. SPIRIVA RESPIMAT is the third FDA-approved product delivered by the RESPIMAT, which is the only inhaler available in the U.S. that uses mechanical energy to generate a slow-moving mist to deliver the medication.
About Spiriva? Respimat? (tiotropium bromide) Inhalation Spray
Indication
SPIRIVA? RESPIMAT? (tiotropium bromide) Inhalation Spray is a prescription medicine used once every day (a maintenance medicine) to relax your airways and help keep them open. COPD includes chronic bronchitis, emphysema, or both.
SPIRIVA RESPIMAT also reduces the likelihood of COPD flare-ups (COPD exacerbations).